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Loratadine

Apotex Corp.
Apotex Inc.

Loratadine Tablet 10 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Loratadine 10 mg

Antihistamine

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
  • safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing
  • store between 2° and 30°C (36° and 86°F)
  • protect from exceesive moisture

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Manufactured by: Manufactured for:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 33326

Revised: March 2005

PRINCIPAL DISPLAY PANEL - 10 mg

APOTEX CORP. NDC 60505-0147-1

Loratadine Tablets 10 mg

Non-Drowsy*

Antihistamine/Original Prescription Strength 

Compare to the active ingredient in Claritin® Tablets

Indoor & Outdoor Allergies

24 hour

Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose Loratadine

Loratadine

Loratadine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:60505-0147
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm LOR;10;APO OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60505-0147-1 100 in 1 BOTTLE
2 NDC:60505-0147-8 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076471 2005-01-24


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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